Under the leadership of Commissioner Scott Gottlieb, M.D., FDA has launched sweeping initiatives intended to accelerate drug and device approvals and clearances, encourage new technologies, and lower regulatory burdens to foster innovation and spur greater competition.

While collectively these are positive developments for the life sciences industry, private equity investors should keep a close watch on the regulatory landscape, particularly since the regulatory changes underway can affect different market players in different ways.

Areas under increased regulatory scrutiny, such as opioids and compounded drugs, may still represent investment opportunities for PE firms that can closely read the lay of the land and move with agility.